Passarini Blog
UDI for Brazil – ANVISA
UDI for Brazil - ANVISA Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil. The UDI is composed of the UDI-DI [...]
Anvisa Quality System Management
ANVISA Quality System Management Implementation and Maintenance If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market. ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the [...]
Resolution of the Directive Board (RDC) 432, ANVISA
Resolution of the Directive Board (RDC) 432, November 4th, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board - RDC nº432 to establish the obligation of describing the composition of personal hygiene products, cosmetics, and perfumes in the Portuguese language on the [...]
Resolution of the Directive Board (RDC) 431, ANVISA
Resolution of the Directive Board (RDC) 431, October 31st, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board RDC 431/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is [...]
Period for payment of FDA Registration annual fee is close | Passarini
Period for payment of FDA annual fee is close! October 1, 2020 opens the deadline for payment of the FY 2021 annual establishment fee. This payment period ends on December 31, 2020. The fee is $ 5,546. You have 90-day window to execute the payment. [...]
FDA extends the implementation period for the UDI rule for CLASS I
FDA: implementation of the UDI rule The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes [...]
Deadline for implementing UDI for CLASS I devices
The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 [...]